On April 8, 2026, Shanghai UniXell Biotechnology Co., Ltd. (“UniXell Biotech”) announced that its independently developed UX-GIP001 Injection, the world’s first induced pluripotent stem cell (iPSC)-derived off-the-shelf cell therapy for drug-resistant epilepsy, received implicit approval for clinical trials from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).

UX-GIP001 Injection was approved for clinical trials within 40 natural days of submission. This rapid approval not only reflects the supportive regulatory environment for innovative drugs in China—particularly the “30-day review pathway” for innovative clinical trial applications—but also demonstrates Yuesai Bio’s strong capabilities in the research, development, and translation of novel cell therapies.

This approval marks UX-GIP001 Injection as the world’s first iPSC-based cell therapy for epilepsy to enter the clinical stage, with IND approvals obtained in both China and the United States. It also represents another core product from UniXell Biotech to achieve dual IND approvals in a short timeframe, following its proprietary Parkinson’s disease cell therapy, UX-DA001 Injection.

Epilepsy is one of the most common and severe neurological disorders, affecting approximately 70 million people worldwide, including around 10 million patients in China. About 30% of these patients suffer from drug-resistant epilepsy.

The therapy directly targets the core pathology of epilepsy—loss of inhibitory GABAergic interneuron function in the brain. By differentiating iPSCs into functional inhibitory neuronal progenitor cells, it aims to restore neural circuitry and rebuild brain function, moving beyond symptomatic treatment toward a disease-modifying paradigm.

Unixell Biotech was founded by Professor Yuejun Chen, a senior investigator at the Institute for Brain Science and Intelligence Technology of the Chinese Academy of Sciences. The core team comprises leading experts from top universities, academia, and industry worldwide. Professor Chen has long focused on stem cell neural differentiation and stem cell-based therapies for neurological diseases. Through the development of the SISBAR technology—a high-throughput single-cell lineage tracing method—his team elucidated the “black box” of neural differentiation. They also established the highly efficient neural differentiation platform SphereDiff and a precise quality control system for cell therapeutics. These achievements have been published in leading journals such as Cell Stem Cell and Nature Methods, with multiple associated patents granted.

Leveraging its proprietary iPSC neural differentiation platform, Unixell Biotech has achieved internationally leading standards in differentiation efficiency and GMP-grade cell manufacturing. This ensures high purity of active cellular components, well-controlled impurity profiles, and strong batch-to-batch consistency, providing a solid foundation for clinical safety and efficacy.

Unixell Biotech has established a 4,000 m² R&D center and GMP-compliant manufacturing facility in the Waigaoqiao Free Trade Zone in Shanghai. The company has received multiple prestigious awards, including the Excellence Award at the National Disruptive Technology Innovation Competition and the Silver Award at the “Hai Ju Ying Cai” Global Innovation and Entrepreneurship Competition. Its innovation has been widely recognized by authorities. Backed by continuous investment from state-owned capital, market-oriented funds, and industrial investors, the company benefits from stable long-term financial support for R&D, clinical development, and commercialization. In addition, Yuesai Bio has established deep collaborations with leading medical institutions such as Ruijin Hospital to accelerate the translation of its innovations.

The dual IND approvals of UX-GIP001 Injection in China and the United States represent another milestone breakthrough for Yuesai Bio in the field of neurological cell therapy. Looking ahead, the company will continue to leverage its proprietary technology platform to advance multiple pipelines of cell therapies for neurological diseases into clinical development, further unlock the clinical potential of cell replacement therapies, and bring more globally leading, China-originated innovative therapies to patients worldwide.